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Monoclonal Antibodies
Durvalumab +/− Lenalidomide for T-Cell Lymphoma
Phase 1 & 2
Recruiting
Led By Christiane Querfeld, MD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Fully recovered from acute toxicities (except alopecia) of all prior therapies to Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1
Female of childbearing potential: negative urine or serum pregnancy test
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial is testing durvalumab with or without lenalidomide to treat patients with cutaneous or peripheral T cell lymphoma that has come back and does not respond to treatment.
Who is the study for?
This trial is for patients with relapsed or refractory cutaneous or peripheral T cell lymphoma. Eligible participants must have confirmed mycosis fungoides (MF) or Sezary syndrome (SS), measurable disease, and adequate organ function. They should not have had certain treatments recently and must be willing to use birth control. Exclusions include prior stem cell transplantation, active infections like HIV, unstable heart disease, severe allergies to similar drugs, and other conditions that could affect safety.Check my eligibility
What is being tested?
The trial is testing the effectiveness of durvalumab alone versus in combination with lenalidomide in treating T cell lymphoma that has returned after treatment. Durvalumab is a monoclonal antibody that may block cancer growth by targeting specific cells, while lenalidomide can stop cancer cells from growing by various mechanisms.See study design
What are the potential side effects?
Potential side effects include immune-related reactions such as inflammation of organs; infusion reactions; blood disorders; increased risk of infection; fatigue; allergic reactions to components of the drugs being tested; skin rash and gastrointestinal issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have recovered from side effects of previous treatments, except for hair loss.
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I am a woman who can have children and my pregnancy test is negative.
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I am able to get out of my bed or chair and move around.
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My blood clotting tests are within normal limits.
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My kidneys are functioning well, with a creatinine clearance rate of 60 mL/min or higher.
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My condition has returned or didn't respond to treatment.
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My lymphoma is confirmed as PTCL by WHO standards.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CTCL specific response assessed by Lugano Classification
Dose limiting toxicity assessed by CTCAE version 4.03
Duration of complete response
+7 moreSecondary outcome measures
Pruritus
Other outcome measures
Changes in biomarkers
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (durvalumab, lenalidomide)Experimental Treatment3 Interventions
Patients receive durvalumab IV over 1 hour on day 1 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 (+/- 3) days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (durvalumab)Experimental Treatment2 Interventions
Patients receive durvalumab IV over 1 hour on day 1. Treatment repeats every 28 (+/- 3) days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Lenalidomide
2005
Completed Phase 3
~1480
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,398 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,272 Total Patients Enrolled
Christiane Querfeld, MDPrincipal InvestigatorCity of Hope Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently being treated for a serious infection.I do not have a stomach or bowel condition that affects how my body absorbs medication.I have or had lung inflammation treated with steroids.I have not received a live vaccine in the last 30 days.I have not received immunotherapy such as checkpoint inhibitors, cell therapies, or cancer vaccines.I need ongoing steroid or immune system treatments and may need more during the trial.I require dialysis for kidney failure.I have had a stem cell transplant before.I have not had any skin treatments in the last 14 days.I have recovered from side effects of previous treatments, except for hair loss.I am a woman who can have children and my pregnancy test is negative.I am not pregnant or breastfeeding.My condition is confirmed as mycosis fungoides or Sezary syndrome, and it's at an advanced stage.I am allergic to thalidomide or durvalumab ingredients.I do not have unstable heart conditions.I have been cancer-free for at least 5 years, except for certain types.I have not taken Lenalidomide, Thalidomide, or similar drugs.I haven't had any systemic therapy or monoclonal antibody treatment in the last 28 days or 5 half-lives, whichever is shorter.I am able to get out of my bed or chair and move around.I have moderate to severe numbness, tingling, or pain in my hands or feet.I have had an autoimmune or inflammatory disorder that needed treatment in the last 3 years.My blood clotting tests are within normal limits.I am using two birth control methods or am not having sex to avoid pregnancy during and 90 days after the study.My kidneys are functioning well, with a creatinine clearance rate of 60 mL/min or higher.My cancer's stage has been identified using the TNM system.My condition has returned or didn't respond to treatment.I have a skin biopsy from the last 6 months for review.My lymphoma is confirmed as PTCL by WHO standards.I haven't taken any monoclonal antibody treatment recently.I will use birth control from the start of the study until 90 days after it ends.I have not had radiation therapy in the last 21 days.I haven't taken immunosuppressive medication in the last 14 days.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (durvalumab)
- Group 2: Arm II (durvalumab, lenalidomide)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum capacity for enrollment in this research project?
"Affirmative. The clinical trial is actively recruiting participants, as noted on the clinicaltrials.gov site. It was initially posted on March 8th 2017 and updated recently on January 28th 2022, seeking 62 individuals from 4 different medical sites."
Answered by AI
How many healthcare institutions are conducting this research study?
"This medical experiment is recruiting subjects from M D Anderson Cancer Center, Thomas Jefferson University Hospital, City of Hope Medical Centre and 4 additional sites. Specifically, these are located in Houston (Texas), Philadelphia (Pennsylvania) and Duarte (California)."
Answered by AI
What medical indications are typically treated with Lenalidomide?
"Lenalidomide is primarily prescribed to treat chronic lymphocytic leukemia, yet it has also been utilized therapeutically for amyloidosis and muscular dystrophy in individuals who have experienced failure under at least two other systemic chemotherapy treatments."
Answered by AI
Are there still open slots for volunteers in this experiment?
"According to the clinicaltrials.gov website, this medical trial is open and recruiting participants since its initial posting on March 8th 2017 and last modification made January 28th 2022."
Answered by AI
Has there been any precedent for using Lenalidomide in research?
"Lenalidomide first hit the clinical research scene in 2004, when Saint Joseph Regional Medical Center-Mishawaka conducted an investigation. Over a thousand studies later, there are presently 598 open studies recruiting participants with many of them taking place in Houston, Texas."
Answered by AI
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